Cysteamine in Cystic Fibrosis

Phase 1

• Conditions: Cystic Fibrosis; MedDRA version: 16.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-000284-40-GB
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-29
• Last Update Posted: 10 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1.CF related suppurative lung disease who expectorate sputum
2.Clinically stable for >4 weeks,
3.Aged =18 years,
4.Weight >50kg.
5.Female participants of child bearing potential should be using a reliable form of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1.Hypersensitivity to the active substance, any form of cysteamine, or to any of the excipients.
2.Hypersensitivity to penicillamine.
3.Lung, liver transplant, on active transplant list.
4.For women, current pregnancy or breast-feeding, or planned pregnancy during the study.
5.Any other significant disease/disorder which, in the investigator’s opinion, either puts the patient at risk because of study participation or may influence the results of the study or the patient's ability to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified